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Civica Rx · 3 days ago

QA Compliance Specialist II (360)

Petersburg, VA

Full-time

Onsite

Senior Level

6+ years exp

Civica Rx is a market-based nonprofit organization dedicated to preventing and mitigating drug shortages in U.S. healthcare. The QA Compliance Specialist II will be responsible for ensuring compliance with regulatory standards and leading quality-related activities at Civica's Petersburg facility, which focuses on the manufacture of essential generic sterile injectable medications.

Pharmaceutical

H1B Sponsor Likely

Responsibilities

Working across functions, participate in the implementation and maintenance of the site’s quality system framework including quality systems and processes necessary to enable the development and reliable supply of Civica generic medications to patients

Implement, track, trend, and analyze quality processes and systems across the product lifecycle including, but not limited to, change control, CAPA, deviations and investigations, label control, laboratory control, product quality complaints, Annual Product Quality Review (APQR), and management notification. Summarize findings and recommendations for management and team awareness and/or present at routine Quality Council meetings

Lead the assessment, qualification, and approval of suppliers

Participate in or lead internal self-assessment audits

Proactively identify and work collaboratively to resolve problems taking risk-based and compliant approaches to solutions

Working across functions to ensure compliant document control and training programs

Lead or participate in Quality Risk Management and Data Governance Processes as needed

Participate in activities to support regulatory agency inspections

Support site objectives with a minimal amount of supervision. Includes simple project management that may involve other functional areas

Promote a quality mindset and quality excellence approach to all activities

Maintain written procedures for personnel qualification and training and support the delivery of compliance training sessions

Travel is limited but may occasionally be required

Qualification

Quality AssuranceRegulatory ComplianceSupplier QualificationRisk ManagementVeevaProject ManagementTraining DeliveryChange ControlCAPAInterpersonal SkillsWritten CommunicationProblem SolvingFlexibilitySelf-MotivatedContinuous LearningTeam Collaboration

Required

6+ years' experience working directly with manufacturing in the pharmaceutical or medical device industries. Appropriate combinations of experience and bachelor-level or higher education

Demonstrated experience conducting and writing compliance and/or risk assessments

Project management, organization, and execution skills are required

Ability to apply technical expertise to solve problems and issues

Participating in and leading activities that support regulatory agency inspections is required

Excellent interpersonal and written communication skills and experience using various software/electronic applications required

Self-motivated, flexible, and able to work in a small, fast-paced, dynamic, environment

Ability to work autonomously and within established guidelines, procedures, and practices

Committed to delivering high-quality results, working with others to overcome challenges, and focusing on what matters

Continuously looking for opportunities to learn, build skills, and share knowledge with others

Preferred

Experience with Veeva

Yellow belt or other belt certification

Company

Civica Rx

Glassdoor3.2

Civica Rx was created in late 2018 to secure the supply of important medicines hospitals use every day.

Founded in 2018

Lehi, Utah, USA

51-200 employees

https://civicarx.org/

H1B Sponsorship

Civica Rx has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (7)

2024 (2)

2022 (1)

2021 (2)